HEMOSIL PROTEIN C

K062430 · Instrumentation Laboratory CO · GGP · Sep 1, 2006 · Hematology

Device Facts

• Record ID: K062430
• Device Name: HEMOSIL PROTEIN C
• Applicant: Instrumentation Laboratory CO
• Product Code: GGP · Hematology
• Decision Date: Sep 1, 2006
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 864.7290
• Device Class: Class 2

Indications for Use

HemosIL Protein C is an in vitro diagnostic test for the quantitative determination of Protein C in human citrated plasma based on a synthetic chromogenic substrate. Protein C deficiency is associated with recurrent venous thrombosis, especially in young adults. Acquired deficiencies of Protein C are associated with hepatic disorders, oral anticoagulant therapy and disseminated intravascular coagulation.

Device Story

Modification to HemosIL Protein C assay; update to 'Expected Value' section of package insert regarding normal range; change references normal range to published literature; emphasizes requirement for individual laboratories to establish own normal ranges based on local variables; fundamental scientific technology remains unchanged.

Clinical Evidence

No clinical data; bench testing/design control verification performed.

Technological Characteristics

In vitro diagnostic test using a synthetic chromogenic substrate for quantitative determination of Protein C in human citrated plasma. The device is a reagent-based assay. No changes to technological characteristics compared to the predicate.

Indications for Use

Indicated for quantitative determination of Protein C in human citrated plasma. Used to assess Protein C deficiency, which is associated with recurrent venous thrombosis, hepatic disorders, oral anticoagulant therapy, and disseminated intravascular coagulation.

Submission Summary (Full Text)

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SPECIAL 510(k): Device Modification
ODE Review Memorandum

To: THE FILE
RE: DOCUMENT NUMBER K062430

This 510(k) submission contains information/data on modifications made to the SUBMITTER'S own Class II, Class III or Class I devices requiring 510(k). The following items are present and acceptable (delete/add items as necessary):

1. The name and 510(k) number of the SUBMITTER'S previously cleared device. (For a preamendments device, a statement to this effect has been provided.)
2. Submitter's statement that the INDICATION/INTENDED USE of the modified device as described in its labeling HAS NOT CHANGED along with the proposed labeling which includes instructions for use, package labeling, and, if available, advertisements or promotional materials.
3. A description of the device MODIFICATION(S), including clearly labeled diagrams, engineering drawings, photographs, user's and/or service manuals in sufficient detail to demonstrate that the FUNDAMENTAL SCIENTIFIC TECHNOLOGY of the modified device has not changed.

The modification is to the "Expected Value" section of the HemosIL Protein C assay package insert reference for normal range.

4. Comparison Information (similarities and differences) to applicant's legally marketed predicate device including, labeling, intended use, physical characteristics, and stability. The difference is in the normal range value which is modified to reference a range from published literature, reinforcing the need for each laboratory to establish its own normal range due to the variables which may affect results.
5. A Design Control Activities Summary which includes:
a) Identification of Risk Analysis method(s) used to assess the impact of the modification on the device and its components, and the results of the analysis
b) Based on the Risk Analysis, an identification of the verification and/or validation activities required, including methods or tests used and acceptance criteria to be applied
c) A declaration of conformity with design controls. The declaration of conformity should include:
i) A statement signed by the individual responsible, that, as required by the risk analysis, all verification and validation activities were performed by the designated individual(s) and the results demonstrated that the predetermined acceptance criteria were met, and
ii) A statement signed by the individual responsible, that the manufacturing facility is in conformance with design control procedure requirements as specified in 21 CFR 820.30 and the records are available for review.

6. A Truthful and Accurate Statement, a 510(k) Summary or Statement and the Indications for Use Enclosure (and Class III Summary for Class III devices).

The labeling for this modified subject device has been reviewed to verify that the indication/intended use for the device is unaffected by the modification. In addition, the submitter's description of the particular modification(s) and the comparative information between the modified and unmodified devices demonstrate that the fundamental scientific technology has not changed. The submitter has provided the design control information as specified in The New 510(k) Paradigm and on this basis, I recommend the device be determined substantially equivalent to the previously cleared (or their preamendment) device.

(Reviewer's Signature)
(Date)

Comments

Revised: 3/27/98